This shortage - the result of a multi-year saga involving the pharma-company Mylan, the FDA, and angry nut-fearing parents - highlights the challenges of reining in pharmaceutical price-gouging.
There is a shortage of life-saving EpiPens in America, the FDA has declared. She said the agency "is committed to working closely with the manufacturers to resolve the shortage as quickly as possible".
"A few months ago, Mylan informed FDA of intermittent supply constraints due to manufacturing delays from Pfizer".More news: NASA's newest Mars lander to study quakes on Red Planet
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Meridian Medical has been hit by a series of manufacturing problems. Pfizer manufactures both the branded and authorized generic versions and Mylan is the distributor.
EpiPens and other competing devices deliver doses of adrenaline via an automatic injector that a patient or caregiver can administer in the event of severe allergic reaction, such as to bee stings or exposure to peanuts. Adjusted earnings-per-share were 96 cents, above the FactSet consensus of 95 cents. Overall revenue in the quarter was $2.68 billion, the company said, missing analysts' expectations for $2.74 billion.
North America sales of Mylan's branded products, including EpiPen, fell $108.7 million. Mylan has since lowered the price of EpiPen for certain patients and has also launched its own authorized generic that costs half the price. After the six month mark, there is "significant degradation of the material", he said.
Mylan's EpiPen, the generic version of the same allergic reaction medicine, and a different brand called Adrenaclick were all having supply and distribution issues, according to the FDA.